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Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer (eLEcTRA)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171847
First Posted: September 15, 2005
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche - Prof. Dr. Jens Huober et al.
Information provided by:
Novartis
  Purpose
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

Condition Intervention Phase
Metastatic Breast Cancer Drug: Letrozole Drug: Trastuzumab plus Letrozole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to progression as assessed by clinical palpation and radiologic imaging every 3 months [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Objective response rate/Clinical Benefit rate [ Time Frame: 3 months ]
  • Time to treatment failure [ Time Frame: 3 months ]
  • Duration of response/clinical benefit during treatment [ Time Frame: 3 months ]
  • Overall survival [ Time Frame: 3 months ]

Enrollment: 93
Study Start Date: March 2003
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - HER-2 +ve patients with Femara alone Drug: Letrozole
Experimental: B - HER-2 +ve patients with Femara + Herceptin Drug: Trastuzumab plus Letrozole
Experimental: C - HER-2 -ve patients with Femara alone Drug: Letrozole

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal
  • Her-2 overexpression and ER and/or PgR positive
  • Metastatic Breast Cancer

Exclusion Criteria:

  • Previous treatment with trastuzumab
  • Significant Liver or renal impairment
  • Erbb2 negative and/or ER and PgR negative

Other protocol-defined inclusion / exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171847


Locations
Germany
Novartis Investigative Site
Tuebingen, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Roche - Prof. Dr. Jens Huober et al.
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171847     History of Changes
Other Study ID Numbers: CFEM345C2403
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Novartis:
Breast cancer
Metastatic
Trastuzumab
Letrozole

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Trastuzumab
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs